FDA 510(k) Application Details - K100545

Device Classification Name	Mouthguard, Over-The-Counter   More FDA Info for this Device
510(K) Number	K100545
Device Name	Mouthguard, Over-The-Counter
Applicant	POWER PRODUCTS, INC.-SPLINTEK 9755 RIDGE DRIVE LENEXA, KS 66219 US Other 510(k) Applications for this Company
Contact	MELAINE HASEK Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	OBR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/26/2010
Decision Date	06/04/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review